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Safety, Efficacy and Pharmacokinetics of ALD518 in Patients With Non-Small Cell Lung Cancer-related Fatigue and Cachexia

Primary Purpose

NSCLC, Fatigue, Cachexia

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
ALD518
ALD518
ALD518
Infusion of 0.9% Saline without ALD518
Sponsored by
CSL Behring
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for NSCLC focused on measuring Lung Cancer, Fatigue, Cachexia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Confirmed diagnosis of NSCLC incurable by other treatments including surgery
  • A ≥5 % loss of body weight in the preceding 3 months
  • A C-reactive protein (CRP) concentration ≥ 10 mg/L
  • Life Expectancy of at least 12 weeks

Exclusion Criteria:

  • Treatment with chemotherapy, large-field radiotherapy, or surgery for treatment of cancer in the past 30 days
  • AST/ALT ≥ 3 x ULN at screening
  • Hemoglobin < 8 g/dL at Screening
  • History of or active diagnosis of Tuberculosis

Sites / Locations

  • Rivercity Hospital Research Centre
  • Australian Clinical Research Organisation
  • Royal Adelaide Hospital
  • Palliative Care Launceston General Hospital
  • Cross Cancer Institute
  • Atlantic Health Sciences Corporation
  • McGill University, Department of Oncology
  • A. Gvamichava National Cancer Centre
  • Union Cancer Prevention Centre
  • Medulla Chemotherapy and Immunotherapy Clinic
  • Indira Gandhi Institute of Medical Sciences
  • Dr. Kamakshi Memorial Hospital
  • GKNM Hospital
  • Curie Manavata Cancer Centre
  • Kidwai Memorial Institute of Oncology
  • Kailash Cancer Hospital and Research Centre
  • IndoAmerican Cancer Institute & Research Center
  • SEAROC Cancer Centre
  • Orchid Nursing Home
  • Tata Memorial Hospital
  • Shatabdi Hospital
  • Mahavir Cancer Sansthan
  • Jehangir Clinical Development Centre Pvt. Ltd.
  • P3 Research LTD
  • Oddzial Chorob Pluc i Leczenia Raka Pluc
  • Oddzial Chemioterapii Szpital Morski
  • II Oddzia Chorob Pluc z Pododdzialem Chemioterapii
  • Oddzial II Chemioterapii Specjalistyczny Szpital
  • Professor Dr. Al Trestioreanu Institute
  • Professor Dr. I Chiricuta Institute of Oncology and Radiotherapy
  • Oradea Clinical County Hospital Medical Oncology Department
  • County Hospital Sibiu Medical Oncology Department
  • Territorial Clinical Oncology Dispensary
  • Republic Oncology Dispensary
  • Stavropol Territorial Clinical
  • City Clinical Hospital No. 1
  • Saint-Petersburg State Medical University, I.P. Pavlov
  • St. Petersburg City Oncology Dispensary
  • Yaroslavl Regional clinical Oncology Hospital
  • Institute of Lung Diseases and TB
  • Clinical Hospital Center Bezanijska Kosa
  • Clinical Centre Kragujevac
  • Institute for Pulmonary diseases of Vojvodina

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

1

2

3

4

Arm Description

ALD518

ALD518

ALD518

No ALD518

Outcomes

Primary Outcome Measures

Change in Safety parameters.

Secondary Outcome Measures

Time to symptomatic progressions at Weeks 12 and 24

Full Information

First Posted
March 20, 2009
Last Updated
July 7, 2020
Sponsor
CSL Behring
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1. Study Identification

Unique Protocol Identification Number
NCT00866970
Brief Title
Safety, Efficacy and Pharmacokinetics of ALD518 in Patients With Non-Small Cell Lung Cancer-related Fatigue and Cachexia
Official Title
A Phase II Study to Determine the Safety, Efficacy, and Pharmacokinetics of Multiple Intravenous Doses of ALD518 80 mg, 160 mg, and 320 mg Versus Placebo Administered to Patients With Non-Small Cell Lung Cancer-Related Fatigue and Cachexia
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CSL Behring

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to asses the safety and efficacy of ALD518 in patients with Non-Small Cell Lung Cancer-Related Fatigue and cachexia (weight-loss).
Detailed Description
This is a phase II, double-blind, randomized, placebo-controlled study of ALD518 in patients with NSCLC related fatigue and cachexia. It is estimated that a total of 120 patients will be randomized to ALD518 80 mg, 160 mg, 320 mg, or placebo in a 1:1:1:1 ratio. A total of eight visits (excluding the Screening visit) will take place over a period of 24 weeks: Day 1, Weeks 2, 4, 8, 12, 16, 20, and 24. Enrolled patients will be screened within a 4 week period (Day 35 to 7). Randomization to treatment will be within a 12 day period (Day 14 to 3), before initial dosing on Day 1. Patients will receive treatment eight weeks apart (on Day 1, and Weeks 8 and 16). All patients will remain at the clinic for at least 4 hours from the time the infusion is started. Follow-up visits will occur four and eight weeks after the last dose of study drug, at Weeks 20 and 24, respectively.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
NSCLC, Fatigue, Cachexia
Keywords
Lung Cancer, Fatigue, Cachexia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
124 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
ALD518
Arm Title
2
Arm Type
Experimental
Arm Description
ALD518
Arm Title
3
Arm Type
Experimental
Arm Description
ALD518
Arm Title
4
Arm Type
Placebo Comparator
Arm Description
No ALD518
Intervention Type
Biological
Intervention Name(s)
ALD518
Intervention Description
ALD518 80 mg on Day 1, Week 8 and Week 16
Intervention Type
Biological
Intervention Name(s)
ALD518
Intervention Description
ALD518 160 mg IV on Day 1, Week 8 and Week 16
Intervention Type
Biological
Intervention Name(s)
ALD518
Intervention Description
ALD518 360 mg IV on Day 1, Week 8, and Week 16
Intervention Type
Biological
Intervention Name(s)
Infusion of 0.9% Saline without ALD518
Intervention Description
Infusion of 0.9% Saline without addition of ALD518
Primary Outcome Measure Information:
Title
Change in Safety parameters.
Time Frame
20 weeks
Secondary Outcome Measure Information:
Title
Time to symptomatic progressions at Weeks 12 and 24
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Confirmed diagnosis of NSCLC incurable by other treatments including surgery A ≥5 % loss of body weight in the preceding 3 months A C-reactive protein (CRP) concentration ≥ 10 mg/L Life Expectancy of at least 12 weeks Exclusion Criteria: Treatment with chemotherapy, large-field radiotherapy, or surgery for treatment of cancer in the past 30 days AST/ALT ≥ 3 x ULN at screening Hemoglobin < 8 g/dL at Screening History of or active diagnosis of Tuberculosis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey TL Smith, MD FRCP
Organizational Affiliation
Alder Biopharmaceuticals, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Rivercity Hospital Research Centre
City
Auchenflower
State/Province
Queensland
ZIP/Postal Code
4066
Country
Australia
Facility Name
Australian Clinical Research Organisation
City
Kippa Ring
State/Province
Queensland
ZIP/Postal Code
4021
Country
Australia
Facility Name
Royal Adelaide Hospital
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Palliative Care Launceston General Hospital
City
Launceston
State/Province
Tasmania
ZIP/Postal Code
7250
Country
Australia
Facility Name
Cross Cancer Institute
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Facility Name
Atlantic Health Sciences Corporation
City
Saint John
State/Province
New Brunswick
ZIP/Postal Code
E2l 4L2
Country
Canada
Facility Name
McGill University, Department of Oncology
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2W 1S6
Country
Canada
Facility Name
A. Gvamichava National Cancer Centre
City
Tbilisi
ZIP/Postal Code
0177
Country
Georgia
Facility Name
Union Cancer Prevention Centre
City
Tbilisi
ZIP/Postal Code
0177
Country
Georgia
Facility Name
Medulla Chemotherapy and Immunotherapy Clinic
City
Tbilisi
ZIP/Postal Code
0186
Country
Georgia
Facility Name
Indira Gandhi Institute of Medical Sciences
City
Patna
State/Province
Bihar
Country
India
Facility Name
Dr. Kamakshi Memorial Hospital
City
Pallikaranai
State/Province
Chennai
ZIP/Postal Code
600100
Country
India
Facility Name
GKNM Hospital
City
Pappanaickenpalayam
State/Province
Coimbatore
ZIP/Postal Code
641037
Country
India
Facility Name
Curie Manavata Cancer Centre
City
Nasik
State/Province
Maharashtra
ZIP/Postal Code
422 304
Country
India
Facility Name
Kidwai Memorial Institute of Oncology
City
Bangalore
ZIP/Postal Code
560029
Country
India
Facility Name
Kailash Cancer Hospital and Research Centre
City
Gujarat
ZIP/Postal Code
391760
Country
India
Facility Name
IndoAmerican Cancer Institute & Research Center
City
Hyderabad
ZIP/Postal Code
500034
Country
India
Facility Name
SEAROC Cancer Centre
City
Jaipur
ZIP/Postal Code
302013
Country
India
Facility Name
Orchid Nursing Home
City
Kolkata
ZIP/Postal Code
700 054
Country
India
Facility Name
Tata Memorial Hospital
City
Mumbai
ZIP/Postal Code
400 012
Country
India
Facility Name
Shatabdi Hospital
City
Mumbai
Country
India
Facility Name
Mahavir Cancer Sansthan
City
Patna
ZIP/Postal Code
801505
Country
India
Facility Name
Jehangir Clinical Development Centre Pvt. Ltd.
City
Pune
ZIP/Postal Code
411 001
Country
India
Facility Name
P3 Research LTD
City
Tauranga
ZIP/Postal Code
31-40
Country
New Zealand
Facility Name
Oddzial Chorob Pluc i Leczenia Raka Pluc
City
Bydgoszcz
ZIP/Postal Code
85-326
Country
Poland
Facility Name
Oddzial Chemioterapii Szpital Morski
City
Gdynia
ZIP/Postal Code
81-519
Country
Poland
Facility Name
II Oddzia Chorob Pluc z Pododdzialem Chemioterapii
City
Krakow
ZIP/Postal Code
31-202
Country
Poland
Facility Name
Oddzial II Chemioterapii Specjalistyczny Szpital
City
Szczecin
ZIP/Postal Code
70-891
Country
Poland
Facility Name
Professor Dr. Al Trestioreanu Institute
City
Bucharest
ZIP/Postal Code
022328
Country
Romania
Facility Name
Professor Dr. I Chiricuta Institute of Oncology and Radiotherapy
City
Cluj-Napoca
ZIP/Postal Code
400015
Country
Romania
Facility Name
Oradea Clinical County Hospital Medical Oncology Department
City
Oradea
ZIP/Postal Code
410032
Country
Romania
Facility Name
County Hospital Sibiu Medical Oncology Department
City
Sibiu
ZIP/Postal Code
550245
Country
Romania
Facility Name
Territorial Clinical Oncology Dispensary
City
Krasnodar
State/Province
Krasnodar Territory
ZIP/Postal Code
350040
Country
Russian Federation
Facility Name
Republic Oncology Dispensary
City
Ufa
State/Province
Republic Of Bashkortostan
ZIP/Postal Code
450054
Country
Russian Federation
Facility Name
Stavropol Territorial Clinical
City
Pyatigorsk
State/Province
Stavropol Territory
ZIP/Postal Code
357500
Country
Russian Federation
Facility Name
City Clinical Hospital No. 1
City
Novosibirsk
ZIP/Postal Code
630047
Country
Russian Federation
Facility Name
Saint-Petersburg State Medical University, I.P. Pavlov
City
Saint-Petersburg
ZIP/Postal Code
197022
Country
Russian Federation
Facility Name
St. Petersburg City Oncology Dispensary
City
Saint-Petersburg
ZIP/Postal Code
198255
Country
Russian Federation
Facility Name
Yaroslavl Regional clinical Oncology Hospital
City
Yaroslavl
ZIP/Postal Code
150054
Country
Russian Federation
Facility Name
Institute of Lung Diseases and TB
City
Belgrade
ZIP/Postal Code
11 000
Country
Serbia
Facility Name
Clinical Hospital Center Bezanijska Kosa
City
Belgrade
ZIP/Postal Code
11080
Country
Serbia
Facility Name
Clinical Centre Kragujevac
City
Kragujevac
ZIP/Postal Code
34000
Country
Serbia
Facility Name
Institute for Pulmonary diseases of Vojvodina
City
Sremska
ZIP/Postal Code
21 104
Country
Serbia

12. IPD Sharing Statement

Learn more about this trial

Safety, Efficacy and Pharmacokinetics of ALD518 in Patients With Non-Small Cell Lung Cancer-related Fatigue and Cachexia

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